Compact oronasal patient interface

ABSTRACT

A breathing arrangement includes a patient interface, at least one inlet conduit, and a headgear assembly. The patient interface includes a mouth covering assembly including a cushion structured to sealingly engage around exterior of a patient&#39;s mouth in use, a nozzle assembly including a pair of nozzles structured to sealingly engage within nasal passages of a patient&#39;s nose in use, and a flexible element connecting the mouth covering assembly and the nozzle assembly. The at least one inlet conduit is structured to deliver breathable gas into at least one of the mouth covering assembly and the nozzle assembly for breathing by the patient. The headgear assembly is removably connected to at least one of the mouth covering assembly and the nozzle assembly so as to maintain the mouth covering assembly and the nozzle assembly in a desired position on the patient&#39;s face.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/584,711, filed Jun. 26, 2006, which is the U.S. national phase ofInternational Application No. PCT/AU2004/001832, filed Dec. 24, 2004,which designated the U.S. and claims priority to U.S. ProvisionalApplication No. 60/533,214 filed Dec. 31, 2003, each of which isincorporated herein in its entirety.

FIELD OF THE INVENTION

The present invention relates to a patient interface for use between apatient and a structure to deliver a breathable gas to the patient, suchas is used in gas delivery systems for respiratory therapy. Examples ofsuch therapy are Continuous Positive Airway Pressure (CPAP) treatment,assisted respiration or Non-Invasive Positive Pressure Ventilation(NIPPV).

BACKGROUND OF THE INVENTION

Comfort and effectiveness remain a continuing challenge for engineersand designers of the interface between a mechanical ventilator and apatient. Such patient interfaces are currently employed for a variety ofpurposes including the delivery of non-invasive ventilation or for thedelivery of pressurized air to persons who suffer from sleep disorderedbreathing conditions such as Obstructive Sleep Apnea (OSA). Innon-invasive positive pressure ventilation, a supply of air at positivepressure is provided by a blower to a patient interface through an airdelivery conduit. The patient interface may take the form of a nasalmask, nose & mouth mask, full face mask or nasal prongs.

A mask may comprise (i) a rigid or semi-rigid portion which attachesdirectly to the air delivery conduit and (ii) a soft patient contactingportion. The rigid or semi-rigid portion, known as a shell or frame, maydefine a nose-receiving cavity, or a mouth covering chamber. Other formsof patient interface, such as nasal cannulae, comprise a pair of nasalprongs, nasal inserts or nozzles.

The soft patient contacting portion is typically known as a cushion ormembrane and is generally shaped during manufacture to match the facialcontours of a patient in order to provide the optimum seal.

An inherent characteristic of patient interfaces such as nasal masks ornozzle assemblies is that they do not seal the mouth region. A number ofpatients thus find that during sleep when muscles relax, mouth leak mayoccur. Alternatively some patients are naturally mouth breathers andthus find a nasal patient interface ineffective. Mouth leak isundesirable as among other difficulties, it may result in noise,increased treatment pressure to compensate for the leak or an increasedload on the nasal passages and potentially nasal obstruction or a runnynose.

Patient interfaces such as full face masks or nose and mouth masksaddress this issue by sealing around both the nose and the mouth. Sincenasal bridge anthropometry varies greatly between patients, the softpatient contacting portion or cushion must adapt to the shapes ofindividual patients. Typically this is not achieved for the entire rangeof patients and some form of leak occurs. The problem is heightenedduring sleep when the jaw moves and the head position changes. Thisaction can often serve to dislodge the mask and cause leak. Since leakcan be noisy and results in less-effective treatment, users oftencompensate by tightening the headgear more than is required. This isdetrimental for patient comfort and can cause skin breakdown.

A further problem encountered by patients who are using full face, nasalor nose and mouth masks is that the portion of the patient interfacethat seals around the nasal bridge prevents the patient from wearingspectacles. Additionally it may give the sensation of being closed in,leading to a feeling of claustrophobia, particularly when combined witha mouth-sealing portion. A further disadvantage is that any leaks thatmay occur can affect the sensitive area surrounding the eyes.

One form of nasal assembly known as a nasal puff is described in U.S.Pat. No. 4,782,832 (Trimble et al.). This device has a pair of nasalpuffs together with a plenum chamber held in place with a harnessassembly adapted to be worn over the head of the patient. The devicedoes not provide a mouth seal.

Another form of known nozzle assembly is described in U.S. Pat. No.6,431,172 (Bordewick et al.). The patent discloses a device with nareselements mounted on an inflatable plenum chamber. Again this does notprovide any structure for sealing the mouth.

One typical example of a known nasal mask is described in U.S. Pat. No.5,243,971 (Sullivan et al.). This has a ballooning seal in order to fitthe patient's nose and facial contours but does not provide a mouthseal. The contents of this patent are hereby incorporated bycross-reference.

International publication number WO 01/97893 A1 (Frater et al.), thecontent of which is hereby incorporated by cross-reference, describes amask system for delivering air to a user including a suspensionmechanism. This suspension mechanism allows relative movement between aface-contacting portion and a mask shell.

A known example of a full face mask is described in U.S. Pat. No.6,513,526 B2 (Kwok et al.), incorporated herein by reference in itsentirety. Whilst providing a facial contour and sealing mechanism thatincorporates both the nasal and mouth, this mask cannot flex to adapt tochanges in jaw movement and head position throughout the night.

A known example of a nose and mouth mask is described in U.S. Pat. No.5,560,354 (Berthon-Jones et al.), the content of which is herebyincorporated by cross-reference.

U.S. Patent Publication No. 2002/0069872 A1 (Gradon et al.) describes amouthpiece which seals the oral cavity against ‘mouth leak’. Thismouthpiece includes both intra-oral and extra-oral sealing means and canbe kept in place without the need for straps. International patent WO01/95965 (Gradon et al.) describes a similar mouthpiece for supplyinghumidified gases to a user.

U.S. Pat. No. 6,571,798 B1 (Thornton) describes an oral device forimproving a patient's breathing together with a connecting post thatprovides a standard interface to a CPAP patient interface. The oraldevice is said to extend the lower jaw of the patient and thus open thebreathing passage. The oral device is clenched between the teeth whichmay lead to discomfort and if mask pressures are high can lead to theslow creep of gums around the teeth due to the sustained load.

U.S. Pat. No. 1,873,160 (Sturtevant) describes a cylindrical air chamberheld in position by a mouth portion that extends between the lips andteeth. The mouth portion may prove irritating and lead to discomfortwhen used for long periods.

A problem with patient interfaces which incorporate oral appliances isthat they can be uncomfortable for patients. Therefore, a need hasdeveloped in the art to address the problems of the prior art.

SUMMARY OF THE INVENTION

In accordance with a first aspect of the invention there is provided acomfortable, effective patient interface which provides a supply of airor breathable gas to a patient's nasal passages and which prevents orreduces mouth leak.

In accordance with a second aspect of the invention there is provided apatient interface which can accommodate movement of the jaw of thepatient.

In accordance with another aspect of the invention there is provided apatient interface that provides an effective seal with both thepatient's mouth and the patient's nasal passages.

In one form the invention comprises a mouth covering chamber, a nozzleassembly and a structure to provide flexibility therebetween.

Another aspect of the invention relates to reducing contact area whencompared to most known full face masks. This allows a far reducedheadgear tension to be applied, significantly improving patient comfort.Patient comfort is further enhanced since the patient is less likely tofeel claustrophobic, particularly with the removal of any mass that isclose to the eyes.

In accordance with another aspect of the invention there is provided apatient interface adapted to connect to an air delivery conduit.

In accordance with another aspect of the invention there is provided apatient interface comprising a first chamber which incorporates a mouthcovering chamber, a second chamber which incorporates a nozzle assemblyand a flexible element connecting the first and second chambers.

In accordance with another aspect of the invention there is provided apatient interface comprising a mouth covering chamber, a pair of nozzlesand a flexible attachment member therebetween.

In accordance with yet another aspect of the invention there is provideda patient interface comprising a mouth covering chamber and a pair ofnozzles flexibly attached thereto. The mouth covering chamberincorporates a rigid portion defining the mouth covering chamber and aresilient or compliant patient-contacting portion. The pair of nozzlesare mounted upon the patient-contacting portion.

In accordance with yet another aspect of the invention there is provideda patient interface comprising a mouth receiving assembly and a pair ofnozzles flexibly attached thereto. The mouth receiving assemblyincorporates a rigid portion defining a mouth covering chamber, a gussetportion and a patient-contacting portion. The pair of nozzles aremounted upon a flexible component of the patient-contacting portion.

In accordance with yet another aspect of the invention there is provideda patient interface with a strap routed around the top of the ears.

These and other aspects of the invention will be described in orapparent from the following detailed description of preferredembodiments, in which like elements designate like parts.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 a-d show a dual chamber patient interface in accordance with afirst embodiment of the invention;

FIGS. 1 e-1 h illustrate various embodiments as to connection betweenthe upper and lower chambers;

FIGS. 2 a-c show a dual chamber patient interface in accordance with asecond embodiment of the invention;

FIGS. 3 a-c show a dual chamber patient interface in accordance with athird embodiment of the invention;

FIGS. 4 a-c show a single chamber patient interface in accordance with afurther embodiment of the invention;

FIGS. 5 a-d show front and rear views of a further embodiment of theinvention.

FIGS. 6 a-b show a single chamber patient interface with mouth gussetportion in accordance with a further embodiment of the invention;

FIGS. 7 a-b show views of a single chamber patient interface with mouthgusset portion in accordance with a further embodiment of the invention;

FIGS. 7 c-f show views of an alternative embodiment of a single chamberpatient interface in accordance with a further embodiment of the presentinvention;

FIG. 8 shows a patient interface in accordance with an embodiment of theinvention connected to a headgear routed around the top of the ears;

FIG. 9 shows a patient interface in accordance with an embodiment of theinvention connected to different forms of headgear routed around the topof the ears;

FIGS. 10-12 illustrate various headgear arrangements according tofurther embodiments of the invention;

FIGS. 13-18 d illustrate another embodiment of a single chamber patientinterface;

FIGS. 19-24 d illustrate another embodiment of a single chamber patientinterface;

FIGS. 25 a-25 e illustrate other embodiments of a single chamber patientinterface;

FIGS. 26-28 illustrate another embodiment of a single chamber patientinterface with no nozzles;

FIGS. 29 and 30 illustrate embodiments of a single chamber patientinterface with blocked nozzles;

FIGS. 31-33 c illustrate another embodiment of a single chamber patientinterface with a gusset portion;

FIGS. 34-38 illustrate embodiments of a single chamber patient interfacewith insertable nozzles;

FIGS. 39-40 illustrate embodiments of a patient interface with a mouthappliance;

FIGS. 41-42 illustrate an embodiment of a patient interface with acorrugated frame;

FIGS. 43-56 b illustrate embodiments of nozzle arrangements;

FIGS. 57-62 illustrate embodiments of support members for nozzles;

FIGS. 63-64 illustrate an embodiment of a patient interface with aboomerang-shaped cushion;

FIG. 65 a-65 c illustrates an embodiment of a patient interface with anextended frame;

FIGS. 66 a-67 illustrate an embodiment of a patient interface with aninsertable anti-asphyxia valve; and

FIGS. 68-80 illustrate embodiments of headgear assemblies.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIGS. 1 a-1 d illustrate a first embodiment of the present invention. Asshown in FIG. 1 a, a headgear assembly 1 includes a patient interfacehaving a dual chamber assembly 10 including an upper chamber 12 and alower chamber 14. As shown in FIG. 1 a, the lower chamber 14 is in adisconnected position, while FIGS. 1 b-1 d shown the upper and lowerchambers in a connected position.

Referring to FIG. 1 a, the upper chamber 12 includes a nozzle assembly16 supported by a frame including a first connector on each lateral endthereof, as described in U.S. Pat. No. 7,318,437 and incorporated hereinby reference in its entirety. The nozzle assembly 16 is secured to theframe via a clip 18 which in this embodiment supports a pressuremeasurement port 20. The nozzle assembly 16 may include a pair ofnozzles 17 (see FIGS. 1 c and 1 d).

One or more inlet conduits 22 is supplied with breathable gas underpressure via a joint 24 coupled to an air delivery tube, which in turnis communicated with a blower or air delivery device. The lower chamber14 is connected to the joint 24 via an inlet conduit 35. The joint 24may include three branches (see FIG. 1 b) for connection to the inletconduits 22 and 35.

Each inlet conduit 22 is connected to an elbow connector 26, which ispreferably connected to yoke 28 of strap 30 of headgear assembly 31 viaa locking portion 32. Each elbow connector 26 is coupled to a secondconnector 34. Each respective first connector of the frame may beselectively rotated with respect to the second connectors 34 to allowthe nozzle assembly 16 to be adjusted according to patient requirements,to achieve the best fit.

As best shown in FIG. 1 a, where the upper and lower chambers aredisassembled, a first portion 36 of the lower chamber 14 may beconnected to a second portion 37 of the upper chamber 12. Connection maybe achieved via a conduit 41 (See FIG. 1 e), or preferably a flexibleelement that connects the upper chamber 12 to the lower chamber 14. Theflexible element may comprise one or more thin silicone conduits throughwhich air can pass. It may take the form of any other flexible elementthrough which air can pass however, examples including a spring 43 (FIG.1 f), bellows 45 (FIG. 1 g) or piston mechanism 47 (FIG. 1 h). Theflexible element provides a range of adjustment to adapt to thedifferent geometry of a wide range of patients and in addition allow forany movement of their jaw and head position during sleep. The conduitneed not be flexible if adjustment can occur via flexibility of thecushions of the upper and lower chambers.

Connection between the upper and lower chambers may take several forms,keeping in mind that one main purpose is to maintain the position of theupper chamber 14 relative to the patient's mouth. To that end, theconnection may take the form of a mechanical fastener, such as VELCRO®,snaps, connectors, etc. For example, the top or second portion 37 of theupper chamber 14 may include a hook portion of VELCRO®, while the bottomor first portion 36 of the upper chamber 12 may include the loop portionof VELCRO®. In other forms, the connection may be provided via metal orplastic rivets and/or by use of adhesives. In the case of rivets,flexibility could be provided by virtue of the compliant and flexibleportions of the cushions of the respective upper and lower chambers thatare fastened together. In other forms, the lower chamber 14 may beconnected to a portion of the headgear or to the inlet tubes 22.Moreover, it is not necessary that air can pass between the upper andlower chambers 12, 14, as each has an independent source of pressurizedair.

As shown in FIGS. 1 a-1 d, the lower chamber 14 includes a rigidpolycarbonate frame 38 which defines a mouth covering chamber 40 (seeFIG. 1 c) and a soft (e.g., compliant, resilient) silicone cushion 42which contacts the patient and forms a seal. The lower chamber 14closely resembles the mouth chamber and mouth cushion described in U.S.Pat. No. 5,560,354, the contents of which are hereby incorporated bycross-reference. However it may take a variety of forms, such asdescribed in U.S. Provisional Patent application No. 60/483,622 filed 1Jul. 2003. The cushion 42 may be attached to the frame 38 by connectinga base edge of the cushion 42 to the frame 38, e.g., via adhesivesand/or a tongue and groove arrangement. In another form, connection maybe achieved by stretching the cushion 42 over the outer edge of theframe 38.

The inlet conduit 35 is structured to deliver breathable gas into thelower chamber 14. The inlet conduit 35 may be inserted into an apertureof the frame 38, in which case the tube 35 may be held in place byfriction alone, as best shown in FIGS. 1 b and 1 d. Alternatively, theinlet conduit 35 may be connected to a swivel assembly (not shown) whichin turn is connected to the frame 38. In another alternative, one ormore suitable headgear straps (not shown) can be used to support thelower chamber 14 such that it can move or pivot relative to the upperchamber without the need for connection thereto or a flexible element.

FIGS. 2 a and 2 b show a second embodiment of the invention. In thisembodiment, the lower chamber 14 does not have a direct inlet conduit,like the inlet conduit 35 in FIG. 1 a, but instead the air is directedto the upper chamber 12 via the inlet conduits 22 only. Air travelsthrough the flexible element, i.e., through first and second surfaces 36and 37, from the upper chamber 12 to the lower chamber 14, for example,thus allowing both nose and mouth breathing. FIG. 2 b best showed theposition where the flexible element would be located between the firstand second surfaces 36, 37.

FIG. 2 c shows one example of how the upper and lower chambers 12, 14may communicate with one another. A mechanical fastener 90 includesfirst and second parts 92 and 94. The first part 92 may take the form ofa thin plate attached to an inside surface 37 a of the second part 37formed on the upper chamber 12. The first part includes an aperture 96.The second part 94 may include a thin plate positioned on the insidesurface 36 a of the first part 36 formed on the lower chamber 14. Thesecond part 94 includes one and preferably a plurality of arms 98extending through the upper and lower chambers 12, 14. The arms 98 areresiliently flexible so that shoulder 100 on each arm 98 may be securedagainst a top surface 92 a of the first part, thereby locking the entireassembly together while allowing gas to flow between the upper and lowerchambers 12, 14. The arms 98 may be formed so as to cut through theupper and lower chambers 12, 14 upon assembly, thereby creating thethrough hole. The assembly may provide for multiple holes if desired.

In FIGS. 2 a and 2 b, a plug 48 covers an aperture of the frame 38 wherean inlet conduit could be placed. Therefore, the joint 24 in FIG. 1 aneed not include a separate branch for the conduit 35, or the branchcould be plugged.

In a third embodiment of the invention, as shown in FIGS. 3 a and 3 b,inlet air is directed directly to the lower chamber 14 through a swivelassembly 50. The upper chamber 12 does not have any inlet conduits butinstead the air is directed to the upper chamber 12 by traveling througha conduit extending from the first surface 36 to the second surface 37.The use of a swivel assembly 50 has the advantage that the inlet conduit(not shown, but connected to end 52 of swivel assembly 50) can be routedfrom any direction. Further, nozzle assembly 16 need not be providedwith second connectors 34 and elbow connectors 26 as shown in FIG. 1 a.Instead, a pair of plugs 54 may be placed into each end of the nozzleassembly 16, as described in U.S. Pat. No. 7,318,437 and entitled “NasalAssembly”, incorporated herein by reference in its entirety.

FIGS. 4 a-c schematically show a fourth embodiment of the invention. Inthis embodiment, the mouth covering chamber 40 and the nozzle assembly16 form one chamber with inherent flexibility of the soft siliconecushion 42 upon which the nozzles 17 are mounted providing for movementand changes in alignment between the two. This embodiment of theinvention achieves the advantage of minimizing the volume of the patientinterface which is positioned between the nares and the upper lip.

FIGS. 5 a-5 d illustrate yet another embodiment of the invention. As canbe seen from FIG. 5 a, a swivel assembly 50 provides air from an airdelivery tube (not shown) and supplies it to the mouth covering chamber40 (best shown in FIG. 5 b). The cushion 42 is connected to the rigidframe 38 of the mouth covering chamber 40 via a cushion clip 56. As bestshown in FIG. 5 b, the nozzles 17 are connected or provided directly tothe outer face contacting portion of the cushion 42 which takes the formof a thin silicone membrane 58. The membrane 58 performs the dualfunction of forming a seal around the lips of a patient and additionallysupporting the nozzles 17. The inherent flexibility of the membrane 58provides a range of adjustment to adapt to the different geometry of awide range of patients and in addition allows for any movement of theirjaw and head position during sleep. It should be noted that whilst thisembodiment describes nozzles (which may be in the form of nasal pillows,nasal prongs, cannula, or nasal puffs) 17 of a similar form to thosedisclosed in U.S. Pat. No. 7,318,437, the contents of which are herebyincorporated by cross-reference, they may take the form of any nasalprongs insertable into each nare. As shown in FIG. 5 d, the patientinterface can easily be attached via clips 60 to a headgear assembly 31in order to secure the patient interface to the patient. The headgear 31includes an intermediate strap 31 a extending between clip 60 andconnector 33. The clip 60 and its connection to frame 30 resemble theclip/frame described in U.S. Patent Application Publication 2004/0112384A1, incorporated herein by reference in its entirety.

FIGS. 6 a-b schematically illustrate a fifth embodiment of theinvention. In this embodiment the patient interface includes a mouthcovering chamber 40 incorporating a rigid frame 38, a gusset portion 62and a soft cushion 42. The nozzles 17 are connected directly to theouter face contacting portion of the cushion 42 which takes the form ofa thin silicone membrane 58. The gusset portion 62 includes a flexiblemembrane and has a first side attached to the frame 38 and a second sideattached to the cushion 42, as shown in FIG. 6 b. Pressure within thepatient interface acts upon the increased surface area of the gussetportion 62 projected on the patient's face so as to provide a sealingforce for the soft cushion 42 against the patient's face. In additionthe gusset portion 62 acts to effectively isolate or decouple the rigidframe 38 from the soft cushion 42. In these respects, the gusset portion62 acts in a similar manner to that described in Internationalpublication number WO 01/97893 A1 (Frater et al.), the content of whichis hereby incorporated by cross-reference in its entirety.

Due to its location between the cushion 42 and the frame 38, the gussetportion 62 also acts to decouple the nozzles 17 mounted upon the softcushion 42 from the rigid frame 38. This provides further flexibilitywithin the patient interface which has the advantages previouslydescribed of allowing the interface to adjust to the geometry ofdifferent patients and allowing for any jaw or head movement duringsleep. A further advantage of the gusset portion 62 is that it allowsthe face contacting portion, e.g., membrane 58, of the cushion 42increased freedom to deform in accordance with the contours of the mouthregion than does a direct connection between the cushion 42 and rigidframe 38. Thus the cushion 42 may “wrap around” the mouth region asrequired.

The gusset portion 62 of the embodiment shown in FIGS. 6 a and 6 b is apartial gusset portion in that it is arranged at the chin portion of themouth covering chamber 40. Alternatively the gusset portion 62 may fitaround the entire circumference of the rigid frame 38. An embodiment ofthis is shown in FIGS. 7 a-c. As can be seen from FIG. 7 a, theembodiment includes an inlet swivel assembly 50, a frame 38, a gussetportion 62 and a soft cushion 42 with nozzles 17 mounted thereon.

FIG. 7 b shows the components disassembled, although the swivel assembly50 and frame 38 are shown in an assembled state that could bedisassembled in an alternative embodiment. The headgear clips 60,cushion clip 56 and cushion 42 with gusset portion 62 can also be seenin FIG. 7 b. The clip 56 may include one or more resilient tabs 57 thatengage with corresponding recesses 59, one of which is shown on frame38.

Two alternative cushions, 42A and 42B without gussets are displayed inFIG. 7 b. It should be noted that each of the nozzles 17 on cushion 42Bincludes a simple mound rather than containing a single flexible pleatas do the nozzles on cushion 42 and cushion 42A. The nozzles 17 may alsoinclude a plurality of corrugations and in general the nozzles may takethe form of a nasal puff as described in U.S. Pat. No. 4,782,832(Trimble et al), or as in other known nasal cannulae, such as prongsthat extend into the nares. Further nozzle alternatives are described inU.S. Pat. No. 7,318,437 and entitled “Nasal Assembly.”

FIGS. 7 c-7 f show an alternative embodiment of a patient interfaceassembled to a headgear assembly 31 via clip 60 that is selectivelyadjustable in a rotational sense with respect to yoke 31 attached tostrap 30, as described in U.S. patent application Ser. No. 10/391,440,filed Mar. 19, 2003, incorporated herein by reference in its entirety.Each clip 60 includes opposed arms 64 that may resiliently flex towardsone another to allow engagement and disengagement of claws 66 formed onarms 64. The claws 66 may lockingly engage with corresponding structureor a receptacle 68 formed on or as part of frame 38. In this embodiment,the receptacle 68 may be moved, flexed or pivoted with respect to aportion 38 a of the frame 38, e.g., along pivot axis 70. FIG. 7 d showsthe clips 60 in different angular positions.

FIG. 7 e is an exploded view of clip 60, receptacle 68 and portion 38 aof frame 38. The portion 38 a may be attached to (e.g., via glue) orformed as an integral part of the frame 38. The receptacle 68 includesside chambers 68 a for receiving claws 66 and a central chamber 68 b forreceiving central tab 61 of clip 60. The receptacle 68 may be attachedto portion 38 a, e.g., via a pin and slot assembly. For example, thereceptacle 68 may include opposed arms 69 each including a pin 71. Eachpin 71 can be received within an end 73 of a C-shaped channel 75. Atleast one of the arms 69 or the C-shaped channel 75 may flex to allowassembly and disassembly. Of course, other arrangements for allowingrelative movement are possible.

Alternative headgear may be used, i.e., this embodiment is not limitedto the headgear assembly shown in FIG. 7 c. Vents 72 for the removal ofexcess carbon dioxide are shown in FIG. 7 c. The vents 72 may be formedon an elastic insert, as described in U.S. Pat. No. 6,561,190,incorporated herein by reference in its entirety. FIG. 7 f shows anenlarged patient-side view of the cushion 42 in isolation.

FIG. 8 shows an alternative form of headgear with an occipital strap 74,a coronal strap 76 and a depending strap 78 that is routed to the top ofthe ears. The headgear straps 74, 76, 78 may be rigid or may beconstructed from a laminated foam material such as Breath-O-Prene™. Inone form the headgear straps may be constructed from a combination of asoft comfortable material, such as Breath-O-Prene and a stiffening yoke28 constructed from a polymer, such as nylon, as described inInternational Patent Application PCT/AU03/00458. Angular adjustmentbetween the rigid frame 38 and the headgear, such as that may beachieved via the arrangement shown in FIG. 7 c.

FIGS. 9-12 show the patient interface supported by spectacles-typeheadgear 80. One strap 82 is used as a hook mechanism behind the ear.The strap 82 may be extended to wrap around the head and apply a forceinwards towards the head, as shown in FIG. 9, or the wrap around portionmay be eliminated as shown in FIG. 10. FIG. 11 shows an additionalstabilizing band 84 around the neck. The headgear straps may be formedof any suitable material such as textile, plastic or semi-rigidassemblies. The headgear assembly has the advantage that it covers theminimum head area and therefore is more comfortable than manytraditional designs. In order to improve patient comfort, the headgearmay also require adjustment to suit the head circumference and earheight. It may also be applied to alternative forms of patient interfacesuch as nasal prongs or nose masks.

FIGS. 13-18 d illustrate another embodiment of a patient interface. Asillustrated, the patient interface includes a cushion 42 and a pair ofnozzles 17 flexibly mounted to the cushion 42. The patient interface isformed as a one-piece structure such that the cushion 42 is integrallyformed in one-piece along with the nozzles 17. For example, the cushion42 and nozzles 17 may be formed in an injection molding process as isknown in the art. Also, the cushion 42 and nozzles 17 form one chamberwith flexibility between the cushion 42 and nozzles 17 to provide formovement and changes in alignment between the two.

The cushion 42 includes a non-face-contacting portion and aface-contacting portion. The non-face-contacting portion is structuredto be removably and replacably attached to a rigid frame associated withthe air delivery tube. The non-face-contacting portion may be removablyand replacably attached to the frame in any suitable manner, e.g.,cushion clip, friction or interference fit, and/or tongue-and-groovearrangement, as is known in the art. However, the non-face-contactingportion may be permanently attached to the frame, e.g., by glue and/ormechanical fastening means.

As best shown in FIGS. 15 and 18 a-18 d, the face-contacting portion ofthe cushion 42 includes a side wall 51, a pair of underlying supportrims 53 extending away from the side wall 51, and a membrane 58 providedto substantially surround the rims 53 and provide a sealing structurefor the face contacting portion. The side wall 51 and rims 53 provide asupport structure for the face contacting portion. Also, as best shownin FIG. 16, the face-contacting portion is contoured to follow generallythe curvature of the patient's face.

The membrane 58 is structured to form a seal around the lips of apatient. In the illustrated embodiment, the membrane 58 has asubstantially flat profile. In use, the edge 61 of the flat-profiledmembrane 58 is the first point of contact with the patient's face. Asthe membrane 58 comes more into contact with the patient's face, themembrane 58 conforms to the patient's face with good contact at theinner edge 61 thereof, which reduces the possibility of pressurized aircoming between the skin and the edge 61, thereby improving the integrityof the seal. Also, the edge 61 of the membrane 58 contacts the face andfully extends or stretches the membrane 58, thereby eliminating anywrinkles. A more rounded membrane profile provides a tangential contactwith the patient, potentially providing a leak path under the membranewhen air pressure is applied. Further, the membrane 58 extends furtherthan the edges of the rims 53 to prevent the rims 53 from being a sourceof irritation (e.g., see FIG. 18 b).

The inner edge of the membrane 58 defines an aperture 55 that receivesthe patient's lips. As best shown in FIG. 14, the aperture 55 has agenerally oval shape. However, the aperture 55 may have any othersuitable shape to accommodate variations in the shape of a patient'smouth.

For example, FIGS. 19-24 d illustrate another embodiment of a patientinterface. Similar elements are indicated with similar referencenumerals. As illustrated, the upper edge of the aperture 55 has anarcuate protruding portion. Also, as shown in FIGS. 20 and 21, the upperside of the side wall has an arcuate configuration that corresponds withthe arcuate configuration of the upper edge of the aperture 55. Thus,the plan profile of the cushion 42 shown in FIGS. 20 and 21 is curvedand has a shape similar to a smile. This configuration helps stabilityby more closely following the patient's facial geometry and preventsroll since the cushion 42 is higher at the sides. That is, the cushionshown in FIG. 20 has a greater height than the cushion shown in FIG. 14,which helps with stability. However, the shorter height of the cushionshown in FIG. 14 has a shorter profile and is therefore less obtrusiveto the patient. For example, the cushion in FIG. 20 may have a height ofabout 60 mm and the cushion in FIG. 14 may have a height of about 50 mm.However, the cushion may have any other suitable height. The cushion 42also has a membrane 58 with a substantially flat profile (e.g., seeFIGS. 24 a-24 c), which provides an enhanced seal as described above.

As best shown in FIG. 15, the rims 53 are preferably provided on lateralsides of the side wall only 51. The rims 53 add rigidity to the membrane58 at the sides of the patient's mouth or cheeks. As illustrated, eachrim 53 has a general C-shape and extends inwardly into the cavity of thecushion 42. While it is preferable that the membrane 58 be thinner thanthe rim 53, they could have the same thickness. For example, in FIGS. 18a, 18 c, 24 a, and 24 c, the side wall thickness may be about 3.20 mm,which tapers to about 0.50 mm at the edges of the membrane. In FIGS. 18b and 24 b, the side wall thickness may be about 3.20 mm, which tapersto about 0.50 mm at the edges of both the rim and the membrane. However,the side wall, rim, and membrane may have any other suitablethicknesses.

As shown in FIGS. 18 b and 18 d, the inside surface of the membrane 58is spaced from the outside surfaces of the rims 53 so that the membrane58 can accommodate small variations in the shape of the patient's mouthwithout undue force and can account for small movement of the patientinterface relative to the patient during use, while maintaining aneffective seal. The spacing between the rim 53 and the membrane 58 mayhave any suitable size. Moreover, the rim 53 may extend around theentire perimeter of the side wall, or may have any other suitableconfiguration to support the membrane 58.

In the illustrated embodiment, the face-contacting portion of thecushion 42 has a double-walled construction, i.e., membrane and rim, inthe region of the cheeks and a single-walled construction, i.e.,membrane, under the nozzles 17 and in the region of the chin and/orlower lip. The single wall construction at the top and bottom of thecushion 42 helps to accommodate high landmarks, e.g., pointed chin, byallowing the center of the cushion 42 to flex. This flexibilityaccommodates more patients with the same cushion 42. Also, the singlewall construction under the nozzles 17 alleviates space constraints andpotential occlusion of the nasal air path by a rim. However, the cushion42 may have any other suitable construction, e.g., single walled, triplewalled or more walled construction, in any suitable region of thecushion 42, e.g., cheek, chin, under nozzles. For example, FIG. 25 aillustrates an embodiment of a patient interface substantially similarto the patient interface shown in FIGS. 13-18 d. In contrast, thepatient interface includes a rim 53 that extends around the entireperimeter of the cushion 42 as indicated by the dashed line. Also, therim 53 could be completely removed. FIGS. 25 b-25 e illustrates anembodiment of a patient interface substantially similar to the patientinterface shown in FIGS. 13-18 d (nozzles omitted for clarity purposes).In contrast, the side wall 51 of the cushion 42 has a slightly differentperimeter geometry. The cushion 42 also has a membrane 58 with asubstantially flat profile (e.g., see FIGS. 25 c-25 e), which providesan enhanced seal as described above.

The side wall of the cushion 42 supports the pair of nozzles 17. Similarto the above embodiments, the nozzles 17 may have a similar form tothose disclosed in U.S. Pat. No. 7,318,437, the contents of which arehereby incorporated by cross-reference, however they may take the formof any nasal prongs insertable into each nare.

As illustrated, each nozzle 17 includes a conduit 19 that interconnectseach nozzle 17 with the cushion 42 and allows breathable gas to passfrom the chamber defined by the cushion 42 to the nozzles 17. As shownin FIGS. 14, 16 and 17, the conduits 19 and nozzles 17 attached theretoare angled with respect to the side wall to properly position thenozzles 17 with the nasal passages of the patient. For example, theangle θ in FIGS. 14 and 20 is referred to as the alar angle, the angle αin FIGS. 16 and 22 is referred to as the nostril angle, and the angle βin FIGS. 17 and 23 is referred to as the naso-labial angle. Asillustrated, the angle θ is substantially the same in FIGS. 14 and 20,the difference being that the angle θ in FIG. 14 is defined by thenozzles 17 whereas the angle θ in FIG. 20 is defined by the side wall51. The angles θ, α, and β may have any suitable value and may bedetermined from anthropometric data. For example, the angle θ may bebetween 60°-180°, the angle α may be between 0°-120°, and the angle βmay be between 40°-140°. These angles are merely exemplary and shouldnot be limiting. Also, the nozzles 17, conduits 19, and side wall 51 mayhave any suitable configuration to properly position the nozzles 17 withrespect to the nasal passages of the patient.

Also, the conduits 19 may have different lengths to accommodatedifferent patients. For example, the conduits 19 illustrated in FIGS.13-17 are longer than the conduits 19 illustrated in FIGS. 19-23. Thelonger conduits of FIGS. 13-17 provide more nozzle flexibility, whereasthe shorter conduits of FIGS. 19-23 allow more direct transfer of forcesfrom the side wall support to the nozzles. The conduits 19 may have anysuitable length and may be suitably varied to accommodate variouspatients, e.g., with varying length between the patient's nose and upperlip. For example, in an embodiment, the nozzles 17 are about 8 mm long,which allows good flexibility and articulation while still allowing thenozzles 17 to be loaded adequately to effect seal.

FIGS. 26-28 illustrate an embodiment of a patient interface wherein thenozzles have been removed so that the patient interface includes acushion 42 only. The cushion 42 may have a structure similar to thecushions described above, e.g., side wall 51, a pair of rims 53extending away from the side wall 51 in the cheek regions, and amembrane 58. However, the cushion 42 may have any other suitablestructure to seal around a patient's mouth.

FIGS. 29 and 30 illustrate embodiments of a patient interface thatinclude a cushion 42 and a pair of nozzles 17 that are blocked fromfluid communication with the chamber defined by the cushion 42. In FIG.29, the nozzles 17 are blocked at entrance to the cushion 42. That is,the upper portion of the side wall 51 is not provided with any openingsthat communicate with the nozzles 17. In FIG. 30, the nozzles 17 areblocked at the nozzle tips. That is, the nasal opening of the nozzle 17is blocked so that gas cannot pass through the nozzles 17. The pressurewithin the nozzles 17 aids the seal within the nasal passages of thepatient. In another embodiment, a set of plugs may be inserted into thenozzles 17, e.g., at the top or bottom of the nozzles, to block nasalflow. In these embodiments, the nozzles 17 simply seal the patient'snasal passages, and gas is delivered to the patient's mouth only. Theblocked nozzles may also serve to stabilize the cushion and help withalignment.

FIGS. 31-33 c illustrate an embodiment of a patient interface thatincludes a cushion 42 and a pair of nozzles flexibly mounted to thecushion 42 (nozzles omitted for clarity purposes). As illustrated, thecushion 42 includes a side wall 51 incorporating a gusset portion 62, apair of rims 53 extending away from the side wall 51, and a membrane 58to substantially surround the rims 53 and provide a sealing structurefor engagement with the patient's face.

Similar to the embodiments in FIGS. 13-24 d, the rims 53 are provided onthe lateral sides of the side wall 51 only (e.g., see FIGS. 31 and 33b). However, a rim may be provided around the entire perimeter of theside wall, or at any other suitable portion of the side wall, e.g., chinportion of the cushion. Also, similar to the embodiments in FIGS. 13-24d, the side wall thickness may be about 3.20 mm, which tapers to about0.50 mm at the edges of both the rim and the membrane. The thickenedside wall helps to support the nozzles in proper position.

As best shown in FIGS. 32, 33 b, and 33 c, the gusset portion 62 isprovided on the lateral sides of the side wall 51 and the lower wall ofthe side wall 51 (adjacent the patient's chin). However, the gussetportion 62 may be provided around the entire perimeter of the side wall.Similar to the gusset portion described above in FIGS. 6 a and 6 b, forexample, the gusset portion 62 provides further flexibility within thepatient interface to allow the interface to adjust to the geometry ofdifferent patients, allow for any jaw or head movement during sleep, andallow the membrane 58 of the cushion 42 increased freedom to deform inaccordance with the contours of the mouth region without disturbingnozzle seal. Also, the gusset portion 62 could be replaced by a flexiblespring, or any other suitable structure that would add flexibility.

FIGS. 34-38 illustrate embodiments of a patient interface that include acushion 42 and a pair of nozzles 17 that are selectively mounted to thecushion 42. Specifically, the nozzles 17 are formed separately from thecushion 42, and then secured to the cushion 42 to construct a patientinterface with both cushion 42 and nozzles 17. This arrangement providesa greater scope of patient fitting by being able to select cushion sizeand nozzle size independently. Also, the nozzles 17 may be independentlyaligned with respect to the cushion 42 for optimal fit.

In each of the embodiments, each nozzle 17 includes a nozzle portion 21that seals within a respective patient nasal passage and a base portion23 that is mountable to the cushion 42. The side wall of the cushion 42includes nozzle mounting portions 25 structured to mount a respectivenozzle 17.

The nozzles 17 may be mounted to the cushion 42 in any suitable manner.For example, FIG. 34 illustrates an arrangement wherein the nozzlemounting portions 25 are in the form of inclined platforms 104structured to support a respective nozzle 17 thereon. The base portion23 of the nozzles 17 may be secured to respective platforms 104 in anysuitable manner, e.g., adhesive, male/female connection, etc.

FIG. 35 illustrates an arrangement wherein the nozzle mounting portions25 provide substantially flat mounting surfaces structured to support arespective nozzle 17 thereon. The base portion 23 of the nozzles 17 aresecured to respective surfaces via a male/female connection mechanism.For example, each base portion 23 may include a protrusion that issecured within a respective opening provided in the respective nozzlemounting portion 25 of the cushion 42. However, the nozzles 17 may besecured to the cushion 42 in any other suitable manner.

FIG. 36 illustrates an arrangement wherein the nozzle mounting portions25 are in the form of cylindrical protrusions structured to engagewithin openings provided in the base portion 23 of respective nozzles17. However, the nozzles 17 may be secured to the cushion 42 in anyother suitable manner.

As shown in FIGS. 35 and 36, the nozzles 17 are mounted to the cushion42 such that the nozzles 17 can rotate independently to align eachnozzle 17 with a respective one of the patient's nares. As shown in FIG.36 b, a ball-jointed insert 106 may be incorporated into the nozzles 17to allow greater rotational and angular freedom and allow alignment inall directions. As shown in FIG. 38, the cushion 42 may include angularalignment marks 27 to align the nozzles 17 with respect to the cushion42, which assists the patient in consistent set-up. The marks 27 mayhave any suitable configuration, e.g., detented.

FIG. 37 illustrates an arrangement wherein each nozzle mounting portion25 provides an opening defined by edges having a stepped configuration.The base portion 23 of each nozzle 17 has an annular recess thatreceives the stepped edge of the opening therein, so as to secure eachnozzle 17 within the respective opening. The stepped edge may includeone or more resilient protrusions (in dashed lines) to improve the sealbetween the cushion 42 and nozzles 17. Also, the stepped edge may havemultiple steps to allow for selective height adjustment. However, thenozzles 17 may be secured to the cushion 42 in any other suitablemanner. Also, the nozzle 17 illustrated in FIG. 37 includes a gussetportion 29 that adds flexibility and articulation of the nozzle 17 withrespect to the cushion 42. It should be understood that one or moregusset portions 29 may be provided on each nozzle 17, and the gussetportion 29 may have any suitable configuration to improve nozzleflexibility.

The embodiments of FIGS. 34-37 allow nozzles 17 to be interchanged fordifferent size patient nares, which improves seal and patient comfort.Also, it should be understood that the nozzles 17 could be interchangedindividually, or a single insert could be provided that contains bothnozzles 17.

FIGS. 39-40 illustrate embodiments of a patient interface that include apair of nozzles 17 that are mounted to a mouth appliance 110, e.g., anappliance that sits within a patient's mouth. In the illustratedembodiment, the mouth appliance 110 provides a mouth seal by sandwichingthe inside and outside of the patient's mouth. Specifically, the mouthappliance 110 includes a tongue depressor 112, a soft seal 114 thatabuts against the inner surface of the patient's mouth, and a snap flap116 that abuts against the outer surface of the patient's mouth toprovide an endstop against the appliance being swallowed. An example ofsuch mouth appliance is disclosed in WO200195965, the contents of whichare hereby incorporated by cross-reference. The nozzles 17 are mountedto the mouth appliance 110 by a conduit 19 that allows gas to passbetween the mouth appliance 110 and nozzles 17. The conduit 19 may havea flexible or rigid construction. As shown in the embodiment of FIG. 40,a mask system 118, e.g., similar to a diving mask, may be incorporatedinto the patient interface to improve seal and to help locate thenozzles 17 with respect to the patient's nasal passages. Also, thetongue depressor 112 is optional and may be removed.

FIGS. 41 and 42 illustrate an embodiment of a patient interface having acorrugated frame 38 and a cushion (not visible) with nozzles 17 mountedto the frame 38, or to the cushion. The corrugations in the frame 38 addflexibility to the frame 38 to allow the frame 38 to adjust to thefacial geometry of different patients and to allow for any jaw or headmovement during sleep. For example, the frame 38 may move downwardly forjaw dropping during sleep, and may move rearwardly for receding jaw (seearrows in FIG. 42). As illustrated, the corrugations are provided alonga lower portion of the frame 38. However, the corrugations may extendacross the entire frame 38. The movement may be accomplished viapivoting and/or sliding action of the corrugated frame about the sidesof the frame. In this arrangement, the seal in the lower lip region isthus not compromised even if the jaw moves. Also, frame flexibility maybe provided by other suitable structures, e.g., gusset portion providedin the frame. The frame 38 may be adjusted, e.g., by adjusting thetension in the lower straps of a headgear assembly 31. Further, thecorrugated configuration may be incorporated into a full-face mask.

Also, the frame 38 is structured such that inlet conduits 22 are coupledto the sides of the frame 38 for delivering breathable gas into thepatient interface. However, one or more inlet conduits 22 may be coupledto the frame 38 in any other suitable manner, e.g., to the front of theframe.

FIGS. 43-46 illustrate embodiments of patient interfaces including acushion 42 and a pair of nozzles 17 mounted to the cushion 42. Thenozzles 17 are mounted to the cushion 42 to add flexibility to thenozzles 17 with respect to the cushion 42. For example, FIG. 43illustrates nozzles 17 mounted within respective rounded recesses 120 orscalloped reliefs provided in the side wall of the cushion 42. The depthof the recess 120 may be suitably modified to provide desired variationsof flexibility. For example, the recesses 120 may be relatively deep forgreater flexibility as shown in FIG. 44, or the recesses 120 may berelatively shallow for moderate flexibility as shown in FIG. 45. FIG. 46illustrates an embodiment wherein a radial notch 22 is provided in theconduit 19 that interconnects each nozzle 17 with the cushion 42. Thenotch 22 adds flexibility to the conduit 19 which facilitates movementof the nozzle 17 with respect to the cushion 42.

FIGS. 47-51 illustrate embodiments of nozzles 17 having a nozzle portion21 and a conduit 19 that interconnects the nozzle portion 21 with theside wall of the cushion 42. As illustrated, the cross-sectionalconfiguration of the conduit 19 may be varied to vary the flexibility ofthe nozzle 17. For example, FIGS. 47 and 48 illustrate an embodimentwherein the conduit 19 has a substantially constant cylindricalcross-sectional configuration along its length. FIGS. 49-51 illustratean embodiment wherein the cross-sectional configuration of the conduit19 varies along its length. As illustrated, the conduit 19 has anelliptical cross-sectional configuration near the nozzle portion 21which continuously varies to a cylindrical cross-sectional configurationnear the side wall of the cushion 42. Thus, the conduit has a “swept”cross-sectional configuration. In other embodiments, the nozzles 17 mayinclude anatomically-shaped nozzle portions, and the nozzle portions mayinclude openings that are off-center from the conduit opening.Preferably, the cross-sectional shape of the conduit and the nozzleopening are similar or the same, although dissimilar shapes are alsopossible. Also, the nozzles 17 may be structured to dilate the patient'snose similar to the structure shown in FIG. 18 of U.S. Pat. No.4,782,832, which is incorporated herein by reference.

FIGS. 52-54 illustrate an embodiment of a patient interfaces including acushion 42 and a pair of nozzles 17 mounted to the cushion 42. Asillustrated, the nozzle conduits 19 have a concertina configuration,e.g., accordion-like, which adds flexibility to the nozzles 17 withrespect to the cushion 42. Specifically, the concertina configurationallows both rotational and vertical adjustment of the nozzles 17 withrespect to the cushion 42. For example, FIG. 53 shows a nozzle 17 in aneutral position, and FIG. 54 shows a nozzle 17 stretched and rotatedwith respect to the cushion 42. The concertina configured conduit 19 maybe constructed from a soft silicone material or a stiffer material,e.g., drinking straw material, to allow articulation and extension. Thisconfiguration allows the conduits to be adjustably positioned in anumber of different positions, and maintained in position during use.Also, the nozzles 17 may be integrally formed in one-piece along withthe cushion 42, or the nozzles 17 may be formed separately from thecushion 42 and mounted thereto.

FIGS. 55 a-56 b illustrate embodiments of nozzles 17 for use in apatient interface. As shown in FIGS. 55 a and 55 b, each nozzle 17 mayinclude a gusset portion 29 in the conduit 19 that interconnects thenozzle portion 21 with a cushion. The gusset portion may have anysuitable width. For example, FIG. 55 a illustrates a narrower gussetportion 29, whereas FIG. 55 b illustrates a wider gusset portion 29. Thegusset portion 29 would allow articulation of the nozzle 17 as well asprovide upward pressure of the nozzle 17 into the patient's nasalpassage. That is, the gusset portion 29 allows the change in sealingforce to be in accordance with the change in treatment pressure.

As shown in FIGS. 56 a and 56 b, each nozzle 17 may include a dual wallconstruction. Specifically, the nozzle 17 includes a thin membrane 124that surrounds the upper nozzle portion 21 to enhance the seal of thenozzle 17 with the patient's nasal passage. As illustrated, the uppernozzle portion 21 may include one or more openings 126 for aircommunication to improve inflation of the membrane 124. The openings 126may have any suitable shape, e.g., ring-like, and may have any suitablesize. Also, as shown in FIG. 56 b, each nozzle 17 may include a gussetportion 29 in the conduit 19 that interconnects the nozzle portion 21with a cushion. Further, both embodiments may include more than onemembrane 124, thereby providing a nozzle having a three or more wallconstruction.

FIGS. 57-62 illustrate embodiments of support members for supportingnozzles 17 of a patient interface and properly aligning them with thepatient's nasal passages. For example, FIGS. 57 and 58 illustrate asupport member in the form of a C-shaped spring 130 having openings 132for receiving nozzle conduits therein. The spring 130 is positionedbetween the side wall 51 of the cushion 42 and the nozzle portions 21 ofthe nozzles 17, and provides a biasing force to extend the nozzles 17and maintain a substantially rigid configuration to facilitate properalignment and seal with the patient's nasal passages. The spring 130 maybe constructed of any suitable material, e.g., metal or polymer. Also,additional adjustment may be added to the spring, e.g., additionalbending axis 131 that allows lateral adjustment of the nozzles.

FIGS. 59 and 60 illustrate a support member in the form of an adjustableslider mechanism 134 having a mounting portion 135 and a support portion136 with openings 137 for receiving nozzle conduits therein. Themounting portion 135 is secured to the frame 38 of the patientinterface, e.g., by a fastener, and the support portion 136 is engagedwith the nozzle portions 21 to extend the nozzles 17 and maintain asubstantially rigid configuration to facilitate proper alignment andseal with the patient's nasal passages. As illustrated, the opening 138in the mounting portion 135 for receiving the fastener is elongated,which allows adjustment of the mechanism 134 with respect to the nozzles17. Also, additional adjustment may be added to the mechanism, e.g.,additional bending axis 131 that allows lateral adjustment of thenozzles and bending axis 133 to change the angle of contact between thenozzles and patient.

FIGS. 61 and 62 illustrate a support member in the form of a wedge 140having openings 142 for receiving nozzle conduits therein. The wedge 140is positioned between the side wall 51 of the cushion 42 and the nozzleportions 21 of the nozzles 17, and extends the nozzles 17 and maintainsa substantially rigid configuration to facilitate proper alignment andseal with the patient's nasal passages. The wedge 140 may have variousangles and thicknesses to achieve the optimal alignment and seal of thenozzles 17. Also, additional adjustment may be added to the wedge, e.g.,additional bending axis 131 that allows lateral adjustment of thenozzles. Further, the wedge 140 may be constructed of any suitablematerial, e.g., foam, rigid plastic, elastomeric material such assilicone.

FIGS. 63 and 64 illustrate an embodiment of a patient interface having acushion 42 and a pair of nozzles 17 mounted to the cushion 42. Asillustrated, the cushion 42 is shaped as a boomerang, and may includerims 53 extending from the side wall of the cushion 42.

FIGS. 65 a-65 c illustrate an embodiment of a patient interface whereinthe frame 38 includes extended portions 144 to cover the cheek regionsof the patient's face. This arrangement is structured to prevent or atleast control cheek blowout. Also, as illustrated, the frame 38 isstructured such that inlet conduits 22 are coupled to opposing sides ofthe frame 38 for delivering breathable gas into the patient interface.However, one or more inlet conduits 22 may be coupled to the frame 38 inany other suitable manner, e.g., to the front of the frame.

FIGS. 66 a-67 illustrate an embodiment of a patient interface whereinthe frame 38 includes an inlet conduit 22 coupled to one side thereofand an anti-asphyxia valve module 150 coupled to the opposite sidethereof. It should be understood that the inlet conduit 22 and module150 can be interchanged.

As shown in FIG. 66 b, the anti-asphyxia module 150 includes ananti-asphyxia valve 154 that is housed within an anti-asphyxia cap 156secured to the frame 38. As illustrated, the anti-asphyxia cap 156includes a plurality of openings 157, and the anti-asphyxia valve 154includes a flexible membrane 155 that is movable between operative andinoperative positions. In the inoperative position (shown in solid linein FIGS. 66 c and 66 d), the membrane 155 is spaced from the cap 156 sothat atmospheric air can pass through the openings 157. The membrane 155is moved into the operative position (shown in dotted lines in FIGS. 66c and 66 d) by mask pressure and closes the openings 157 so thatatmospheric air cannot pass through the openings 157. Embodiments ofsuch anti-asphyxia valve and anti-asphyxia cap are disclosed inWO200038772, the contents of which are hereby incorporated bycross-reference.

The anti-asphyxia valve module 150 has the advantage of being in closeproximity to the patient's mouth. The close proximity to the mouthimproves CO₂ washout, is good for the stability of the system (i.e.,there is not a heavy weight located at a distance from the patientinterface), and is fail safe if the anti-asphyxia valve module 150 isnot attached to the device. As illustrated, the frame and/or cushion mayinclude an exhaust vent 152. Also, headgear 31 is attached to frame 38in any suitable manner to maintain the cushion and nozzles in a desiredadjusted position on the patient's face. In the illustrated embodiment,the headgear 31 includes a strap that extends below the ears and aroundthe upper portion of the patient's neck, and a strap that extends infront of the ears and over the top of the patient's head. However, theheadgear 31 may include any other suitable strap arrangement.

FIGS. 68-70 illustrate an embodiment of a headgear assembly 160removably coupled to the frame 38 of a patient interface so as tomaintain the cushion and nozzles in a desired adjusted position on thepatient's face. As illustrated, the headgear assembly 160 includes twostraps each having an independent attachment to the frame 38.Specifically, the headgear assembly 160 includes an upper strap 161, alower strap 162, and a connecting strap 163 that interconnects the upperand lower straps 161, 162. Each end of the upper and lower straps 161,162 includes an attachment member 164 adjustably secured thereto. Eachattachment member 164 is interlockable with a respective anchor 165 a,165 b provided on the frame 38 as discussed in greater detail below.

As best shown in FIGS. 68 and 70, each attachment member 164 includes acrossbar 166 that enables respective end portions of the straps to bewrapped around, in a known manner. The free ends of the straps include astrip of hook material 167 attached thereto by stitching, for example,that engages the loop material of the remainder of the strap to securethe attachment member in place. The hook/loop arrangement, e.g.,Velcro®, allows adjustment of the straps with respect to the attachmentmember 164. Each attachment member 164 is in the form of a femaleconnector that includes a relatively large lead-in opening 168 a thatleads into a relatively smaller attachment opening 168 b.

The frame includes a main body and side frame member provided on eachlateral side of the main body. The main body includes an aperture thatis coupled to an inlet conduit (22) for delivering breathable gas. Upperand lower anchors 165 a, 165 b on each side thereof. As best shown inFIG. 69, each anchor is in the form of a male connector, e.g.,protruding knob. In use, each attachment member 164 is interlocked witha respective anchor 165 a, 165 b by first moving the attachment member164 adjacent the respective anchor 165 a, 165 b such that the respectiveanchor 165 a, 165 b extends through the larger opening 168 a, and thenthe attachment member 164 is moved to interlock the respective anchor165 a, 165 b with the smaller opening 168 b. As shown in FIG. 68, theattachment members 164 on the ends of the lower strap 162 are adapted toreleasably interlock with respective lower anchors 165 b on the frame38, and the attachment members 164 on the ends of the upper strap 161are adapted to releasably interlock with respective upper anchors 165 aon the frame 38. As shown in FIG. 70, a soft flexible finger tab 169 isprovided on the end of each attachment member 164 to facilitateengagement and disengagement of the attachment member 164 to the frame38. As illustrated, the free end of the finger tab 169 may include aball-like shape.

When mounted, each attachment member 164 is substantially flush with theframe 38. As a result, this arrangement provides no protrusions that canlead to inadvertent disengagement of the straps. Also, there are noobstructions to the patient, e.g., when sleeping on his/her side.

Also, the arrangement enables intuitive and dexterous attachmentmovement, permits quick release of the patient interface, and theattachment member 164 may be freely rotated with respect to the anchor165 a, 165 b to allow the patient interface to self-align on thepatient's face.

When mounted on a patient, the upper and lower straps 161, 162 followtwo vectors to effect mask stability. Specifically, the lower strap 162extends below the ears and around the upper portion of the patient'sneck and the upper strap 161 extends over the ears and around a topportion of the patient's head. The connecting strap 163 extends alongthe rear portion of the patient's head, which holds the lower strap 162in place during head rotation. One or more of the straps may be flared,e.g., at the rear, in order to better conform with the contours of thepatient's head which helps reduce head pressure from strap tension.

The above arrangement enables the patient interface to be balanced,e.g., by tuning the patient interface so that sufficient pressure isapplied to regions of the cushion and nozzles so an adequate seal isattained. Also, the above arrangement positions the straps away frompatient's face.

FIGS. 71-73 illustrate another embodiment of a headgear assembly 170removably coupled to the frame 38 of a patient interface. Asillustrated, the headgear assembly 170 includes two straps each havingan independent attachment to the frame 38. Specifically, the headgearassembly 170 includes an upper strap 171 and a lower strap 172. Each endof the upper strap 171 includes an upper locking clip 173 a securedthereto and each end of the lower strap includes a lower locking clip173 b secured thereto. Each locking clip 173 a, 173 b is interlockablewith a respective clip receiver 174 a, 174 b provided on the frame 38 asdiscussed in greater detail below.

As illustrated, each upper clip 173 a includes a crossbar 175 thatenables respective end portions of the upper straps 171 to be wrappedaround, in a known manner. In the illustrated embodiment, each free endof the upper strap 171 is secured to the remainder of the strap, e.g.,by stitching, to secure the clip in place. Also, an intermediate portionof the upper strap 171 includes an adjustable ladder lock arrangement176 for adjustment purposes. Each lower clip 173 b includes anadjustable ladder lock arrangement 177 that enables respective endportions of the lower strap 172 to be engaged, in a known manner. Eachfree end of the lower strap 172 is held in place to the remainder of thestrap by a watch strap style retainer 178. However, the straps may besecured to the clips 173 a, 173 b in any other suitable manner, e.g.,Velcro®. Further, each clip 173 a, 173 b includes a side wall having alongitudinally extending slot 180 that leads into a transverselyextending slot 181.

The frame 38 includes upper and lower clip receivers 174 a, 174 b oneach side thereof. As best shown in FIG. 73, each clip receiver 174 a,174 b includes a resiliently flexible tab 182 having a ramped surfaceleading to a locking shoulder 183 and a release projection 184. In use,each clip 173 a, 173 b is interlocked with a respective clip receiver174 a, 174 b by first moving the clip receiver 174 a, 174 b into therespective clip 173 a, 173 b such that the release projection 184extends through the longitudinally extending slot 180 until the lockingshoulder 183 interlocks with the transversely extending slot 181 with asnap fit. The clip 173 a, 173 b may be released from the respective clipreceiver 174 a, 174 b by depressing the release projection 184 until thelocking shoulder 183 releases from the transversely extending slot 181.As shown in FIG. 71, the lower clips 173 b on the ends of the lowerstrap 172 are adapted to releasably interlock with respective lower clipreceivers 174 b on the frame 38, and the upper clips 173 a on the endsof the upper strap 171 are adapted to releasably interlock withrespective upper clip receivers 174 a on the frame 38. The cliparrangement may provide audible feedback when the clip 173 a, 173 b isattached to the respective clip receiver 174 a, 174 b.

Also, as shown in FIG. 73, each clip 173 a, 173 b may be rotatablyengaged with the respective strap such that the clip 1731, 173 b may befreely rotated with respect to the strap to allow the patient interfaceto self-align on the patient's face.

Similar to the above-described headgear arrangement, the lower strap 172extends below the ears and around the upper portion of the patient'sneck and the upper strap 171 extends over the ears and around a topportion of the patient's head.

FIGS. 74-76 illustrate another embodiment of a headgear assembly 190removably coupled to the frame 38 of a patient interface. Asillustrated, the headgear assembly 190 includes two straps with a singlepoint of attachment to the frame 38. Specifically, the headgear assembly190 includes an upper strap 191 and a lower strap 192. One end of theupper and lower straps 191, 192 is adjustably secured to one attachmentmember 193, and the other end of the upper and lower straps 191, 192 isadjustably secured to another attachment member 193. Each attachmentmember 193 is interlockable with a respective anchor 194 provided on theframe 38 as discussed in greater detail below.

As best shown in FIG. 76, each attachment member 193 is generallyV-shaped and includes a upper and lower crossbars 195 a, 195 b thatenable respective end portions of the straps 191, 192 to be wrappedaround, in a known manner. The free ends of the straps 191, 192 includea strip of hook material attached thereto by stitching, for example,that engages the loop material of the remainder of the strap to securethe attachment member in place. The hook/loop arrangement, e.g.,Velcro®, allows adjustment of the straps 191, 192 with respect to theattachment member 193. However, the straps 191, 192 may be secured tothe attachment member 193 in any other suitable manner, e.g., adjustableladder-lock arrangement. Each attachment member 193 includes arelatively large lead-in into a relatively smaller attachment opening196.

The frame includes an anchor 194 on each side thereof. As best shown inFIG. 75, each anchor 194 is in the form of a protruding knob. Moreover,each anchor 194 is mounted on a sliding adjustment mechanism that allowssliding adjustment of the anchor 194 between upper and lower portions ofthe frame 38. Specifically, the anchor 194 is mounted on a slide 197that is movable by a button 198 by sliding the button 198 within a slotto adjust the anchor height. The adjustment mechanism may be held inposition by, e.g., frictional engagement, detents that would allow fordiscrete steps of movement.

In use, each attachment member 193 is interlocked with a respectiveanchor 194 by first moving the attachment member 193 adjacent therespective anchor 194 such that the anchor 194 extends through thelead-in, and then the attachment member 193 is moved to interlock theanchor 194 with the smaller attachment opening 196. As shown in FIG. 76,a spring mechanism 199 may be incorporated into the opening 196 so thatthe connection does not wear. As shown in FIG. 74, each end of the frame38 interlocks with a respective attachment member 193, and eachattachment member 193 secures ends of the respective upper and lowerstraps 191, 192. As illustrated, a soft flexible finger tab 200 isprovided on the end of each attachment member 193 to facilitateengagement and disengagement of the attachment member 193 to the frame38. As illustrated, the free end of the finger tab 200 may include oneor more protrusions for finger grip. Also, the headgear straps 191, 192are preferably elastic to help with fitting.

The arrangement enables intuitive and dexterous attachment movement,permits quick release of the patient interface, and the attachmentmember 193 may be freely rotated with respect to the anchor 194 to allowthe patient interface to self-align on the patient's face.

Similar to the above-described headgear arrangements, the lower strap192 extends below the ears and around the upper portion of the patient'sneck and the upper strap 191 extends over the ears and around a topportion of the patient's head.

FIGS. 77 and 78 illustrate another embodiment of a headgear assembly 210removably coupled to the frame 38 of a patient interface. Asillustrated, the headgear assembly 210 includes two straps with a singlepoint of attachment to the frame 38. Specifically, the headgear assembly210 includes an upper strap 211 and a lower chin strap 212. One end ofthe upper and lower straps 211, 212 is adjustably secured to oneattachment member 213, and the other end of the upper and lower straps211, 212 is adjustably secured to another attachment member 213. Eachattachment member 213 is interlockable with a respective anchor 214provided on the frame 38 as discussed in greater detail below.

As best shown in FIG. 78, each attachment member 213 includes an upperclip receiver 215 and a lower crossbar 216 As illustrated, end portionsof the upper strap 211 are secured to respective locking clips 217(e.g., strap wrapped around clip cross-bar and free end of the strap issecured to the remainder of the strap by Velcro® arrangement), which arereleasably interlocked with a respective upper clip receiver 215. Theinterlocking engagement may be similar to the snap-fit clip arrangementdisclosed in FIGS. 71-73. Respective end portions of the lower strap 212are wrapped around a respective lower cross-bar 216, in a known manner.The free ends of the lower straps 212 may engage the remainder of thestrap via a Velcro® arrangement. Each attachment member 213 alsoincludes a relatively large lead-in into a relatively smaller attachmentopening 218.

The frame 38 includes an anchor 214, e.g., in the form of a protrudingknob, on each side thereof. The anchors 214 may be mounted on a slidingadjustment mechanism similar to that shown in FIGS. 74 and 75. In use,each attachment member 213 is interlocked with a respective anchor 214by first moving the attachment member 213 adjacent the respective anchor214 such that the anchor 214 extends through the lead-in, and then theattachment member 213 is moved to interlock the anchor 214 with thesmaller attachment opening 218. As shown in FIG. 78, a spring mechanism219 may be incorporated into the opening 218 so that the connection doesnot wear. As shown in FIG. 77, each end of the frame 38 interlocks witha respective attachment member 213, and each attachment member 213secures ends of the respective upper and lower straps 211, 212. Asillustrated, a soft flexible finger loop 220 is provided on the side ofeach attachment member 213 to provide a means for quick disengagement ofthe attachment member 213 from the frame 38. Also, the headgear straps211, 212 are preferably elastic to help with fitting.

The arrangement enables intuitive and dexterous attachment movement,permits quick release of the patient interface, and the attachmentmember 213 may be freely rotated with respect to the anchor 214 to allowthe patient interface to self-align on the patient's face.

When mounted on a patient, the lower strap 212 extends downwardly andaround the patient's chin and the upper strap 211 extends over the earsand around a top portion of the patient's head.

FIGS. 79-80 illustrate another embodiment of a headgear assembly 230removably coupled to the frame 38 of a patient interface. As shown inFIG. 79, the headgear assembly 230 includes an upper strap 232 and alower strap 234. However, the lower strap 234 is optional. Also, thestrap may have two-strap configuration wherein upper and lower straps232, 234 are incorporated into a single structure as shown in FIG. 80.Each end of the straps includes an attachment member 236 adjustablysecured thereto. Each attachment member 236 is interlockable with arespective anchor 238 a, 238 b provided on the frame 38 as discussed ingreater detail below.

Each attachment member 236 may be secured to a respective end of thestrap in any suitable manner, e.g., stitching, Velcro®. Also, eachattachment member 236 includes an attachment opening.

The frame 38 includes upper and lower anchors 238 a, 238 b on each sidethereof. Each anchor 238 a, 238 b is in the form of a protruding knob.In use, each attachment member 236 is interlocked with a respectiveanchor 238 a, 238 b by moving the attachment member 236 adjacent therespective anchor 238 a, 238 b such that the respective anchor 238 a,238 b extends through the attachment opening.

As shown in FIG. 79, the upper anchor 238 a is mounted on a rotatableplate 240 that allows the position of the upper anchor 238 a to berotatably adjusted. This arrangement allows the angle of the patientinterface with respect to the patient's face to be adjusted. Moreover,the arrangement allows the headgear assembly 230 to remain in the sameposition relative to the patient's head even as the angle of the patientinterface changes. Rotation may be discrete with specific indexedpositions, or rotation may be continuous with the desired position beingmaintained by friction.

A soft flexible finger tab 242 is provided on the end of each attachmentmember 236 to facilitate engagement and disengagement of the attachmentmember 236 to the frame 38. As illustrated, the free end of the fingertab 242 may include one or more gripping protrusions.

Also, all the headgear assemblies described above may incorporaterigidizing elements (via insertion of rigid panels, stitiching,lamination, or other means) to add rigidity to the headgear assembliesto aid in mask stability.

It should be understood that the cushion 42 and nozzles 17 describedabove may be formed from any suitable material. For example, the cushion42 and nozzles 17 may be formed from a gel-like material, or they may beformed from a foam-like material. Also, the cushion 42 and nozzles 17may be formed separately from one another, or may be integrally formedas a one-piece structure.

Further, although the above embodiments are described in relation tonozzles, nasal prongs (which are inserted into the nose) and/or nasaldilators are also contemplated.

Advantages of illustrated preferred embodiments may include:

-   reducing significantly the bulk required to form an effective nasal    and oral seal. This has the advantage of creating a less intrusive    patient interface that significantly reduces the problems of patient    claustrophobia. The removal of the requirement to seal around the    nasal bridge provides the opportunity for the patient to wear    spectacles. In addition this removes the danger of leaks affecting    the sensitive eye region, thereby reducing the possibility of    creating conjunctivitis style problems.-   reducing the force (headgear tension) required to maintain the seal    as compared to current full face masks in the prior art. The force    is reduced due to the reduction in the effective area of the cushion    on to the face. As a result, there is less area over which the    pressure inside the patient interface acts and the resultant    headgear tension is reduced.-   improving seal as it avoids the nose bridge region where leak    commonly occurs, thus the force required to deform the cushion and    effect a seal is also reduced. The reduction in the headgear tension    and cushion to face force would substantially reduce the discomfort    to a patient.

The reduction in the area of the face across which a seal must be formedallows a single size or shape to fit a wider range of patient geometry.This is particularly advantageous for a clinician since the patientinterface is both easier to fit to a new patient and potentially moreforgiving of fitting errors. The independent nature of the chambers dueto the flexible connection, also allows for some movement of the faceduring the night without loss of seal. This leads to far more stabilitythan conventional single chamber full face masks.

The provision of flexibility allows the seal to remain throughout jawand head position movement as well as providing adjustment for thedifferent geometry of a wide range of patients. The task of fittingvarying patient geometry is made easier by the removal of the need toseal around the complex form of the nasal bridge which is found in mostof the prior art masks that seal both the nasal and oral passages. Thelack of seal around the nasal bridge also allows the patient to wearspectacles.

Although the invention has been described with reference to theillustrated embodiments, it is to be understood that the illustratedembodiments are merely illustrative of the application of the principlesof the invention. Numerous modifications may be made therein and otherarrangements may be devised without departing from the spirit and scopeof the invention.

1. A respiration assist mask for supplying a positive gas pressure to amouth and nose of a user, the mask comprising: a ventilation interfacedefining a gas entry port to be fluidically connected to a positive gaspressure source supplying a gas to said ventilation interface; acushioned facial interface connected to said ventilation interface, saidfacial interface having a gas exit shaped to gas-tightly seal from theenvironment only the mouth of the user when applied to the user's face;and a removable nasal interface fluidically coupling said gas entry portwith nares of the user when said nasal interface is applied to theuser's nose.
 2. The mask according to claim 1, wherein said ventilationinterface has at least one exhalation port.
 3. The mask according toclaim 2, wherein said exhalation port is selected from at least one ofthe group consisting of bleed nipples, variable bleed ports, anddiffusers.
 4. The mask according to claim 2, wherein said exhalationport is a plurality of exhalation ports.
 5. The mask according to claim1, wherein: said ventilation interface has a front surface, a topsurface, a bottom surface, and two side surfaces; and said gas entryport is disposed on at least one of said front surface, said topsurface, said bottom surface, and said side surfaces.
 6. The maskaccording to claim 1, wherein said facial interface is removably andsubstantially gas-tightly connected to said ventilation interface. 7.The mask according to claim 1, wherein said facial interface is integralwith said ventilation interface.
 8. The mask according to claim 1,wherein said ventilation interface is relatively rigid and said facialinterface is relatively flexible.
 9. The mask according to claim 8,wherein said facial interface feels relatively softer than saidventilation interface.
 10. The mask according to claim 1, wherein: saidventilation interface has two circumferential, rearwardly projectingwalls defining a groove therebetween; and said facial interface has aforward wall removably and substantially gas-tightly secured in saidgroove.
 11. The mask according to claim 10, wherein: said walls eachhave a user-face-side with a given thickness and an opposite side with athickness greater than said given thickness; and said facial interfacehas a forward wall shaped to securely and substantially gas-tightly fitbetween said walls.
 12. The mask according to claim 1, wherein saidfacial interface has a face-contacting periphery forming the onlycontact point between the face of the user and both of said ventilationinterface and said facial interface.
 13. The mask according to claim 1,wherein said gas exit is shaped to completely surround only the mouth ofthe user.
 14. The mask according to claim 1, wherein said gas exit isshaped to completely surround the mouth and a chin of the user.
 15. Themask according to claim 1, wherein said facial interface has a chinportion and a face-contacting periphery.
 16. The mask according to claim15, wherein said chin portion is shaped to extend around and include atleast a part of a chin of the user.
 17. The mask according to claim 15,wherein said chin portion is shaped to extend around and includesubstantially all of the chin of the user.
 18. The mask according toclaim 1, wherein said facial interface is of an elastomeric-material.19. The mask according to claim 1, wherein said facial interface is of amaterial having a durometer between 20 and
 80. 20. The mask according toclaim 1, wherein said nasal interface is disposable.
 21. The maskaccording to claim 1, wherein said facial interface has an upper surfacedefining a nasal interface connection area at which said nasal interfaceis connected.
 22. The mask according to claim 21, wherein said nasalinterface is fixedly attached at said upper surface.
 23. The maskaccording to claim 21, wherein said nasal interface is removablyconnected at said upper surface.
 24. The mask according to claim 21,wherein said nasal interface is removably connected to said uppersurface in a form-fitting connection.
 25. The mask according to claim21, wherein said nasal interface has two separate nasal pillowsrespectively delivering the gas to the user's nares of the nose when atleast one of said nasal interface and said facial interface are placedat the user's face.
 26. The mask according to claim 25, wherein saidpillows are connected to one another with a connecting member.
 27. Themask according to claim 26, wherein said pillows have central axestilted with respect to one another.
 28. The mask according to claim 25,wherein said pillows are of the same material as said facial interface.29. The mask according to claim 21, wherein each nasal pillow has abottom end formed with a first connecting surface and said upper surfacedefines a second connecting surface forming a substantially gas-tight,removable connection when said first and second connecting surfaces areconnected together.
 30. The mask according to claim 25, wherein saidupper surface defines two portals respectively receiving one of said twonasal pillows therein in a substantially gas-tight fit.
 31. The maskaccording to claim 30, wherein: each of said pillows has a bottom endformed with rings defining at least one groove therebetween, said atleast one groove having a given width; and each of said portals has aninterior surface having a thickness no greater than said given width formating with said rings in a substantially gas-tight connection when saidnasal pillows are placed inside said portals.
 32. The mask according toclaim 21, wherein: said upper surface has a removable insert defining aportion of said upper surface substantially gas-tightly connected tosaid upper surface when connected at said upper surface; said nasalinterface has two nasal pillows; and said insert defines two portalsrespectively receiving one of said two nasal pillows therein in asubstantially gas-tight fit.
 33. The mask according to claim 21,wherein: said upper surface defines an insert orifice; and said nasalinterface is a removable insert substantially gas-tightly connected tosaid upper surface and defining a portion of said upper surface whenconnected at said upper surface, said nasal interface having twointegral nasal pillows projecting upward for connecting to the nares ofa user's nose.
 34. The mask according to claim 1, wherein any two ofsaid nasal interface, said ventilation interface, and said facialinterface are integral and a remaining one of said nasal interface, saidventilation interface, and said facial interface is removably attachedto said two integral other interfaces.
 35. The mask according to claim1, wherein said ventilation interface and said facial interface areintegral and are of two different materials.
 36. The mask according toclaim 1, wherein: said nasal interface, said ventilation interface, andsaid facial interface are integral to form a one-piece oral and nasalmask; said facial interface has an upper surface; and said nasalinterface is two nasal pillows projecting upward from said uppersurface.
 37. The mask according to claim 1, wherein: said facialinterface and said ventilation interface defining a first interiorbreathing chamber fluidically connected to said gas entry port forreceiving the gas therein; and said nasal interface defines a secondinterior breathing chamber fluidically connected to first chamber forsupplying the gas to the user's nose.
 38. The mask according to claim37, wherein: said ventilation interface has a swiveling elbow connectorfor attaching said ventilation interface to the gas pressure source; andsaid elbow connector is fluidically connected to said first chamber. 39.The mask according to claim 1, further comprising an adjustable headgearconnected to at least one of said ventilation interface and said facialinterface for pressing said ventilation interface against the face ofthe user and maintaining a substantially gas-tight seal between theuser's face and said facial interface when said headgear is placed on auser's head.
 40. The mask according to claim 1, wherein said ventilationinterface, said facial interface, and said nasal interface form a maskselected from one of a continuous positive airway pressure mask, abi-level positive airway pressure mask, an intermittent mechanicalpositive pressure ventilation mask, and a ventilation mask.